Radioabsorbent Assemblies

ABSTRACT

A system of shields designed to provide substantially greater protection, head to toe, against radiation exposure to health care workers in a hospital room during procedures which require real-time imaging. The shields are placed around the patient and the x-ray table and provide protection even when the x-ray tube is moved to various angles around the patient.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/402,260 filed Aug. 13, 2021 entitled Radioabsorbent Assemblies, whichis a continuation of U.S. patent application Ser. No. 16/559,500 filedSep. 3, 2019 entitled Radioabsorbent Assemblies (now U.S. Pat. No.11,191,495 issued Dec. 7, 2021), which is a continuation of U.S. patentapplication Ser. No. 16/005,339 filed Jun. 11, 2018 entitledRadioabsorbent Assemblies (now U.S. Pat. No. 10,441,231 issued Oct. 15,2019), which is a continuation of U.S. patent application Ser. No.15/291,941 filed Oct. 12, 2016 entitled Radioabsorbent Assemblies (nowU.S. Pat. No. 10,016,172 issued Jul. 10, 2018), which claims benefit ofand priority to U.S. Provisional Application Ser. No. 62/240,409 filedOct. 12, 2015 entitled Radioabsorbent Assemblies, all of which arehereby incorporated herein by reference in their entireties.

FIELD OF THE INVENTION

The present invention pertains to various embodiments of radiationshields to protect physicians and other health care workers presentduring procedures requiring real-time X-ray imaging.

BACKGROUND OF THE INVENTION

Radiation exposure during medical procedures requiring x-rays or otherionizing radiation is a major health concern for health care workers(HCW). Procedures requiring real-time imaging, such as percutaneousprocedures, involve a patient on a table with an x-ray device mounted ona C-arm, known as an x-ray gantry. The radiation is emitted from a“tube” on the bottom of the C-arm and is directed upward through thebottom of the table and the patient. The physician and other attendingHCWs are typically standing next to the table attending the patient andare subject to the radiation.

Most of the radiation exposure to the HCWs emanate from x-ray photonsthat are reflected off of the patient's bones and other structuresduring the procedures. More specifically, the exposure to the HCWs fromtheir waists down result from x-rays coming directly from the tube, aswell as reflecting off of the table structure and the bones of thepatient. Exposure to the HCWs from their waists up result from X-raysreflecting off of the bones of the patient and structures above thepatient.

Most are composed of an x-ray blocking material in the form of a hard,planar shield. These are attached to the ceiling or x-ray table. Someare flexible and some are clear. They are cumbersome, do not conform tothe patient's anatomy (reducing effectiveness in blocking x-rays), donot facilitate surgical access to the body, and do not provide storagefor tools or lighting.

Additionally, these shields are heavy and often get in the way ofadequate fluoroscopic visualization of the patient or key areas of thepatient that require easy access or monitoring. The HCW has to movethese heavy shields manually and also conform their bodies to visualizearound the impediments caused by the existing devices. This is a majorcause for musculoskeletal morbidity of the HCW resulting in chronicneck, back injuries. Consequently, it is common for the HCW to sacrificeradiation protection for better visualization as well as betterergonomics by moving the current shields out of the way or positioningthem in a markedly sub-optimal protection position. Finally, it is notuncommon that the HCW forgets to move the shields for adequateprotection.

Other x-ray blocking shields have consisted of draping x-ray absorbingmaterial (DXAM) over the patient during procedures. Because these drapedmaterials lay on the patient, they need to be covered with sterilematerial or be disposed of after every use. This is cumbersome and, as aresult, most of the draped material is made as a disposable item(disposable drape and x-ray barrier inside), increasing cost and toxicwaste. Moreover, the draped polymer is heavy and uncomfortable for thepatient because the patient supports the weight. Additionally, becausethe DXAM is positioned under the sterile drape that covers the patient,it is difficult to remove during the procedure should an emergency arisethat requires more x-ray visualization.

Another problem in protecting personnel from scatter x-ray exposureduring medical procedures is that, when the x-ray source is below thepatient, the x-ray is scattered off of the patient toward the floor. Asa result, the legs and feet of personnel are heavily exposed to ionizingradiation. In addition, the x-ray tube housing can often leaksubstantial x-radiation, often of high energy. This also increasespersonnel exposure to high energy ionizing radiation.

Current shielding for “below-the-table” radiation consists primarily ofa radiation blocking barrier (called the table skirt) that hangs fromthe table. Since the table height is varied during the procedure, thereis often a gap between the floor and the barrier. Additionally, thesetable skirts are usually hung on a lever arm from the foot end of thex-ray table. They do not cover the gap between the table and the floorfrom the mid abdomen to the head. As a result, personnel in the roomstationed at the patient's head or side receive substantial radiationexposure. This is a particular risk for physicians performing proceduresthat require manipulation of catheters near the patient's head (such assubclavian or jugular vein access, subclavian artery access, ortransesophageal ultrasound imaging).

SUMMARY OF THE INVENTION

There is thus a need for a shielding system that allows a HCW access toa patient while protecting the HCW from radiation. The inventiondescribed herein provides several embodiments directed toward providingprotection both below and above the waist as well as protecting HCWslocated in various positions relative to the patient.

The system of the invention includes a suite of shields and accessoriesthat provide protection and convenience to HCWs working in x-ray imagingenvironments. The suite includes several components that extend from, orare attachable to a sled that carries a mattress and is attachable to anx-ray table. The radiation protection suite of the invention includestable shields, which extend below the table and protect the HCWs fromthe waist down. The suite also includes vertical flags that extendupwards and across the body of the patient. The suite further includesbody shields, which extend upward from the sled and run along the sidesof the patient. Wing shields are also included, which also extend upwardalong the sides of the patient. The wing shields are generally higherand more rigid than the body shields, providing more protection in highdosage areas. Finally, a tray is provided that extends horizontallyacross the body of the patient and provides both shielding as well as awork surface for the HCWs.

Mini Sled

In one aspect of the invention a “mini-sled” is provided. In particular,the shielding drape is connected actively or passively to a sled thatholds a mattress on which the patient lies during the medical procedure.The sled has a bottom that lays on the x-ray table and two perpendicularsides, typically about 1-4 inches in height. A mattress lies within theU-shaped cavity of the sled. The sled can be the entire length of themattress or shorter length. The table shield drape is positioned overthe sled passively (by gravity) or actively attached. The activeattachment can be reversible (such as by a zipper or hook and eyemechanism) or non-reversible (such as with a bonding agent).

In one embodiment, attachment points for arm boards, shields or otherdevices protrude from the sled through the tray shield and attach tosuch devices. In the preferred embodiment, the arm boards rotate on theattachments to the sled, such that they can be flush to the sides of thesled in the down position, parallel to the x-ray table in the neutralposition, or vertical above the sled in the up position. This allowsstowage when transferring a patient off of the bed (down position),support of the patients arms during the procedure (neutral position), orclearance of the x-ray gantry when a lateral view is desired (upposition). In addition, in the preferred embodiment, the arm boardspivot outward from the head-ward attachment, allowing the arm to abduct.This feature is important for optimal arm positioning for radialarterial catheterization.

Table Shields

One aspect provided by the invention is a shielding drape, or “tableshield” that extends down from the top of the sled toward the floor.Through experimentation it has been found that an HCW attendingtableside to a patient undergoing imaging absorbs significant levels ofradiation in their legs and feet that have been historically ignored.Measurements of radiation exposure during use prove that assumptionsthat the tube housing of the imaging device protects the HCW fromradiation exposure are wrong.

A table shield of the invention virtually eliminates below-the-tablescatter radiation exposure to personnel. In addition, attachmentsmarkedly reduce scatter radiation from the patient's head, chest,abdomen, and pelvic area.

A table shield of the invention is constructed of a flexibleradioabsorbent material such as vinyl fabric, that covers the patientprocedure mat and table, where the sides of the material containradiation blocking material sandwiched within the vinyl material

In one embodiment, the table shield has two or more layers of fabric orother material in the portion that lays across the x-ray table ormattress situated on the x-ray table. Electrical conduction pathsbetween the two layers are used to monitor the patient's physiologicparameters, deliver therapeutic gasses or electrical power, or controlother devices. In one embodiment, a capacitive electrocardiographicsystem is sandwiched between the two layers, where the leads aresituated under the patient and a system for conducting the electricalsignal to a detector passes between the layers of the table shield.Similar device sensors or therapeutic devices can be mounted into thespace between the shield layers.

In another embodiment, the surface of the table shield is treated toretard the growth of infective agents such as bacteria (using silverimpregnation, quanternary ammonium salts, or other agents). In anotherembodiment, an electrical heating element between the table shieldlayers can be activated, causing the surface temperature of the othertable shield to rise to above 161 degrees Fahrenheit, therebypotentially providing a reduction in the number of infective agents.

The table shield may include vertically-oriented, curved slats or staysthat are shaped to cause the drape to curve inwardly and under the x-raytable when hanging passively from the table. The extension of the drapeinside the outline of the x-ray table is accomplished by providing acurve in the stays that bow the shield out from the table a smalldistance and then curve under the table for a shorter distance. Thiscreates a center of gravity of the hanging shield such that the lowerportion will passively hang under the table. The inward curve intersectsthe scatter radiation under the table and prevents radiation fromexiting from beyond the outlines of the table, thereby providing moreprotection without requiring the drape to extend all the way to theoperating room floor.

Another aspect of the table shield is that the flexible material iseasily moved by the tube when the C-arm swings to oblique angles.Protection is maintained while the stiffening stays prevent the flexiblematerial of the table shield from folding or sagging over the tube andinterfering with the imaging beam. This will allow the physician toobtain unobstructed patient fluoroscopy images at various angles withoutinterference from the shielding system. Moreover, the flexible nature ofthe shield will still provide personnel protection when the shield ispushed upward by the x-ray gantry.

In one aspect, the shielding system rests on the x-ray table, allowingit to move with the patient and provide scatter radiation shieldingaround the circumference of the patient from the pelvis to the head.This is of particular importance to personnel who must stand near thehead or chest.

Other aspects of the table shield of the invention include stays thatcan be straight or they can consist of articulated components such thatthe stays passively flex, allowing the shield to bend around the x-raytube housing but still hold the shielding out of the path of the primaryx-ray beam. The stays can be permanently fixed to the flexible materialor they can slip into a pre-sewn or formed track within the shield.

Physicians may need to bring the x-ray tube housing and gantry to aposition where the beam is directed through the sagittal plane of thepatient (often referred to as a “cross-table lateral view”). In thiscase, the table shield described would cover the x-ray beam. Theflexible table shield described may be manually moved out of the wayduring rotation of the gantry into the cross-table lateral view,allowing it to drop back into a vertical position once the gantryreached the horizontal orientation and cleared the flexible tableshield.

In another embodiment, one side of the table shield would be reversiblydetachable, allowing the x-ray tube housing to rotate above the x-raytable. In another embodiment, the table shield would only cover aportion of the circumference of the x-ray table. For example, if nopersonnel were station on the patient's left side, that side of theshield could be omitted.

Flag Shield

Another aspect of the invention provides a transverse flag shield withan element that attaches the flag to the sled, the patient's mattress,the table the patient lies on, a free standing device or to a wall orceiling mount. The attachment mechanism has one or more rigid armsconnected at an angle, such that an arm(s) are horizontal and extendfrom the Attachment mechanism. Below one of the arms is a radiationabsorbing material configured in such a way as to conform to thepatient's body. Above the same or another arm is a radio-absorbingmaterial that can be reversibly displaced. For example, an x-ray cameracan be positioned such that it passively pushes away only a portion ofthe upper part of the shield obstructing the camera to allow the camerato be positioned for a particular x-ray view. This passively minimizesthe gap in x-ray blockage.

One aspect of the invention provides a flag having elements to conformto patients' body habitus and other elements to flexibly and reversiblydeform to accommodate other equipment in the environment of theoperating room. Even though the upper unit of the flag shield ispartially displaced, the lower functional unit is allowed to remain inplace on the patient continuing to block radiation scatter from thepatient's body while the upper unit bends away and conforms to the imageintensifier. In addition, the flag shield can mate with the tray shieldto seal the gap between the shields and prevent radiation leakagebetween the devices. In this way, the lower element of the flag shieldconforms to the patient, the upper level of the shield conforms to thex-ray equipment movement, and the flag and table shield mate to eachother, providing a complete blockage of x-radiation leakage.

The elements of the flag may have vertical supports throughout. Thesupports contain a hinges or a spring apparatus to allow the flag tobend in the vertical plane. This allows the flag to conform to otherradiation absorbing material, such as a tray of the invention, allowingthe flag to form a shell around the patient to continue blocking theradiation scatter. Because the flag has elastic properties, when theimage intensifier moves away from an interfering position, the flagreturns to its initial position, preventing gaps in the shielding whereradiation may be emitted towards the HCW.

Another aspect provides a flag with asymmetric curves, which contour toa patient's body habitus, in the lower functional unit to maximizeradiation protection to the HCW. This novel invention contrasts withcurrent devices, which are pushed out of the way by the imageintensifier or the HCW to prevent getting in the way of the HCW beingable to work with catheters etc. The present invention, conversely,allows the lower portion of the flag to stay in place without movingaway and also adds the ability of the upper functional unit to continueto offer radiation protection. This combination minimizes or eliminatesthe interference to the HCW work flow and allows them to continue theirprocedure uninterrupted.

The connection between the flag shield and tray shield may be mechanicalinterference fit, detents, magnetic attraction or other means.

Body Shields

In another embodiment, personnel scatter radiation exposure above thetable is attenuated by attachment to the flexible table shield, or tothe shield that covers the x-ray table, one or more radiation shieldscover various body parts, but particularly the pelvis, chest andshoulder/neck areas.

In one embodiment, rigid or flexible stays within the attached bodyshields keep the shield in an expanded state while allowing the shieldto conform to the body contour. In one embodiment, the stays allow theshield to be folded easily (such as by rolling the shield perpendicularto the stays) and in a further embodiment, magnets within the stays helpmaintain the shield in a folded position.

Since patient and procedure needs vary, the body shields can bereversibly detachable from the table shield using a variety ofmechanisms, such as a zipper or hook and eyelet mechanism.

The body shields may be used instead of, or in addition to, the wingshields.

Wing Shield

Another aspect of the invention, used in conjunction, or independentlyof, a tray is one or more vertical shields that extend upwardly from thetable to a variable height. The shields aid in preventing radiationexposure to the HCW resulting from oblique or horizontal beams comingfrom deflecting surfaces, such as the patient's bones, the bottom of thetray, or other equipment, or radiation traveling directly from the tubeat oblique angles due to the tube being positioned at oblique angles tothe patient.

The invention provides shields designed for placement at variouslocations relative to the patient. These shields move passively whenpushed by the x-ray equipment and then return to their original positionwhen the x-ray equipment moves away.

Side shields, or “wings” attached to the arm board or sled extendvertically along the side of the patient, creating a wall of a desirableheight between the HCW and the patient. The wing shields can bedisplaced passively by x-ray equipment. In one embodiment, the wingshields are attached to the patient arm board using a spring hinge. Thewing shield is pushed away from the patient when the x-ray system isrotated to a lateral position (such as 45 degrees right anterioroblique) and returns to its upright position when the x-ray equipment ismoved to an anterior-posterior position.

The wing may have a number of shapes depending on the room andequipment. In one embodiment, the wing shield is curved from top tobottom, contains a clear window to observe the patient, and/or hasdeflector pieces that interact with the x-ray system to deflect theshield when the x-ray system approaches the wing shield from theheadward or footward edges.

Workbench Shield Directly Above Patient

One aspect of the invention provides a tray assembly as an alternativeto a DXAM drape over the patient. The tray placed over a portion of thepatient forms a radiation blocking workbench used by the physicianduring the procedure. The tray is generally horizontal and may curvedownward on the end facing the operator. The tray is positioned acrossthe patient's body near the vascular access site so that catheters andother tools may rest on a level surface rather than on the arm or legsof the patient. The tray is composed of a radio-opaque material thatblocks x-radiation. The radio-opaque material absorbs x-ray photonsemitting from the patient while the patient is undergoing an x-rayimaging procedure. The curve of the tray blocks radiation emitting fromthe side or legs of the patient. The operator radiation exposure istherefore reduced.

The tray may be connected to an attachment apparatus that connects thedevice to a supporting structure (such as the mini-sled or a bed orx-ray table). The attachment apparatus is fastened to the sled, mattressor table that the patient lies on or to a side-rail attached to asupporting structure. A mechanism in the attachment apparatus allows thetray to rotate around the axis of the attachment apparatus, to flip uptoward the attachment apparatus, and to tilt with one edge of the traycloser or farther away from the patient. The attachment mechanism itselfcan travel in a vertical up and down motion to move the tray above thepatient and to lower the tray to the patient's body. This allows thetray to be positioned across and just above the patient easily, whichallows the device to accommodate patients of different body shapes. Italso allows for the tray to be removed up and out of the way quickly incase of emergency, and to allow for ease of patient transfer onto andoff of the mattress.

Another aspect of the invention provides a tray that is of a laminarconstruction with one or more layers of radio-opaque material and one ormore layers of material with minimal x-ray absorption (such as carbonfiber).

In another embodiment the tray is composed a clear x-ray absorbingmaterial such as a clear plastic polymer with a high content of an x-rayabsorbing material (such as boron, beryllium, barium).

In another embodiment, the tray has attachments that do not absorbx-rays, such as a piece that connects to the attachment apparatus andthe tray.

In another embodiment, the tray has a forward edge that curves upward tomore comfortably rest against the patients belly to further blockradiation from the body. In addition, this edge can mate with the flagattachment, creating a radiation blocking seal between the two devices.The connection between the workbench shield and the flag shield can bepassive or active (such as with magnets or using mechanical means).

In another embodiment, the flag shield and the workbench shield can bepermanently fixed and function at a single shield.

In another embodiment, the tray is attached to a free standing device.

One embodiment of the tray has cut outs to facilitate access to parts ofthe body, such as the femoral artery and vein, while minimizing x-raytransmission. In addition, radio-opaque flaps or barriers attached tothe access sites can be opened and closed to allow access when the x-rayis off. In addition, ridges may be used near the access site to blockx-ray photons that are directed at the operator's position.

One aspect of the invention is a tray that has attachment devices tohold sterile surgical instruments, imaging devices, or supplies. Theseattachments allow the operator to have free hands for other tasks, sucha puncturing an artery while the attachment holds an ultrasound probe tovisualize the artery through the skin. In one embodiment, theattachments are connected to the tray underneath the sterile barrier orsurgical drape and in another embodiment, the instruments are attachedover a sterile barrier or surgical drape. These connections between theattachment and the tray may be mechanical (such as a clip under thedrape) or magnetic (with the attachment containing a magnetic componentthat mates with a magnetic component within the tray under the drape).

In one aspect of the invention, the tray also has indentations thatprovide storage areas for surgical devices and supplies, such asneedles, guidewire attachments, gauze, suture, and sterile fluids. Inaddition, the tray has spring clips and other attachment devices to holdcatheters and wires emanating from the body. This stabilizes thepositions of the catheters or wires and frees-up the operator's hands.

In one or more embodiments, a light may be attached to the trayilluminates the surgical area. The light may be controlled by a switchon the tray or by a remote device (such as a wireless device). The lightcan provide general lighting to the procedure area or a focused light ona particular area of interest. The lights are often dimmed in the x-rayimaging rooms and white light can interfere with the operators viewingof procedure monitors. In one embodiment, lights of different colors areused to provide lighting that optimizes the viewing of x-ray and vitalsign monitors.

In another embodiment, the tray, which is positioned over the body, isused to assist in a procedure by placing force on the body. During sometypes of surgical procedures, pressure needs to be applied to the body,for example, to stop bleeding or compress a hematoma. This can bechallenging when the bleeding occurs next to the surgical site. Theoperator needs to be manipulating catheters or surgical devices andcannot press on the body at the same time. An assistant's hands in thefield obstruct the operator's hands. A tray is provided with a balloonor active device under the tray can be inflated or activated to producepressure on the body. When a balloon is employed, the balloon can beinflated by an electric pump, a manual pump operated by an assistantoutside the sterile field, a manual pump pumped through the drape by theoperator. Alternatively, a simple broad foot can be extendedmechanically (such as a ratchet mechanism) down from the lower surfaceor side of the tray and mechanically locked into place.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1 is side elevation of an embodiment of a mini-sled of theinvention;

FIG. 2 is a top plan view of an embodiment of a mini-sled of theinvention;

FIG. 3 is a side elevation of an embodiment of a mini-sled and tableshield of the invention;

FIG. 4 is an end cutaway view of an embodiment of a mini-sled and tableshield of the invention;

FIG. 5 a is an end cutaway view of an embodiment of a mini-sled andtable shield of the invention;

FIG. 5 b is an end cutaway view of an embodiment of a mini-sled andtable shield of the invention;

FIG. 6 is an is a side elevation of an embodiment of a mini-sled andtable shield of the invention;

FIG. 7 is a manufacturing step of an embodiment of a table shield of theinvention;

FIG. 8 is a manufacturing step of an embodiment of a table shield of theinvention;

FIG. 9 is a manufacturing step of an embodiment of a table shield of theinvention;

FIG. 10 is a perspective view of a patient on a table outfitted with anembodiment of a flag and an embodiment of a wing of the invention;

FIG. 11 is an elevation of a flag of the invention;

FIG. 12 is a side elevation of a flag of the invention;

FIG. 13 is a side elevation of an embodiment of a body shield installedon a mini-sled of the invention;

FIG. 14 is a perspective view of an embodiment of a tray and anembodiment of a wing of the present invention;

FIG. 15 is a plan view of an embodiment of a tray of the invention;

FIG. 16 a is a depiction of an embodiment of the tray being repositionedrelative to a patient;

FIG. 16 b is a depiction of an embodiment of the tray being repositionedrelative to a patient;

FIG. 16 c is a depiction of an embodiment of the tray being repositionedrelative to a patient;

FIG. 16 d is a depiction of an embodiment of the tray being repositionedrelative to a patient;

FIG. 17 is an end view of an embodiment of a tray of the inventionshowing relationship to a patient, mattress, table and operator;

FIG. 18 is a side elevation of an embodiment of a tray of the invention;

FIG. 19 a is a side elevation of an embodiment of a tray having acompression mechanism of the invention;

FIG. 19 b is a side elevation of an embodiment of a tray having acompression mechanism of the invention;

FIG. 20 is a top plan view of an embodiment of a tray of the inventionhaving an adjustable width;

FIG. 21 is a diagram of an experiment conducted to determine theeffectiveness of the various embodiments of the invention;

FIG. 22 is a graph showing the data collected at the variousdata-gathering points diagrammed in FIG. 21 ;

FIG. 23 is a graph showing the data collected at the variousdata-gathering points diagrammed in FIG. 21 ;

FIG. 24 is a graph showing the data collected at the variousdata-gathering points diagrammed in FIG. 21 ;

FIG. 25 is a graph showing the data collected at the variousdata-gathering points diagrammed in FIG. 21 ;

FIG. 26 is a graph showing the data collected at the variousdata-gathering points diagrammed in FIG. 21 ; and

FIG. 27 is a graph showing the data collected at the variousdata-gathering points diagrammed in FIG. 21 .

DETAILED DESCRIPTION

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

The system of the invention includes a suite of shields and accessoriesthat provide protection and convenience to HCWs working in x-ray imagingenvironments. The suite generally includes several components thatextend from, or are attachable to a sled (body length) or mini-sled(torso length) that carries a mattress and is attachable to an x-raytable. The sled does not have radiation protection properties but actsas a foundation for the radiation protection suite, though all of thecomponents of the suite are not necessarily attached to the sled.

The radiation protection suite of the invention includes table shields,which extend below the table and protect the HCWs from the waist down.The suite also includes vertical flags that extend upwards and acrossthe body of the patient. The suite further includes body shields, whichextend upward from the sled and run along the sides of the patient. Wingshields are also included, which also extend upward along the sides ofthe patient. The wing shields are generally higher and more rigid thanthe body shields, providing more protection in high dosage areas.Finally, a tray is provided that extends horizontally across the body ofthe patient and provides both shielding as well as a work surface forthe HCWs.

The various components of the system are now detailed, with referencebeing made to the Figures.

Sled/Mini-Sled

Referring now to FIGS. 1 and 2 , an embodiment of a “mini-sled” 10 ofthe invention is provided. Generally, the sled 10 is a shallow, U-shapedframe that holds a mattress M on which the patient lies during themedical procedure. The sled 10 has a bottom 12 that lays on the x-raytable and two perpendicular sides 14, typically about 1-4 inches inheight. The sled 10 can be the entire length of the mattress or shorterlength. A pair of arm boards 16 are connected to the perpendicular sides14 of the sled 10 with posts 18. A sheath 19 extends down under the sled10 and is sized and shaped to receive a standard x-ray table T forsecurement thereto.

Table Shields

Turning now to FIGS. 3-9 , there are shown embodiments of a table shield100 of the invention. Table shield 100 prevents an HCW from radiationthat is either reflected off of the various surfaces under the x-raytable, or directly from the x-ray tube. The table shield 100 isconstructed of a flexible material such as vinyl fabric, that covers thepatient procedure mat and table, where the sides of the material containradiation blocking material. The surface of the table shield may betreated to retard the growth of infective agents such as bacteria (usingsilver impregnation, quanternary ammonium salts, or other agents). Inanother embodiment, an electrical heating element between the tableshield layers can be activated, causing the surface temperature of theother table shield to rise to above 161 degrees Fahrenheit, therebypotentially providing a reduction in the number of infective agents.

The table shield 100 generally includes a side table shield 102 and across table shield 120. The side table shield 102 is positioned over thesled 10 passively (by gravity) or actively attached. The activeattachment can be reversible (such as by a zipper or hook and eyemechanism) or non-reversible (such as with a bonding agent). The crosstable shield 120 contains radiation blocking material and is attachedbeneath the table to the sled sheath 19. The cross table shield 120extends across the width of the table at a point relative to the patientthat is below the areas desired to be viewed on x-ray.

The side table shield 102 may include vertical slats or stays 104 thatare curved or otherwise shaped to cause the shield to curve inwardlywhen hanging from the table, as seen in FIG. 4 . The curved stays 104reside in pockets 106 formed between the layers of the table shield 100.

FIG. 4 illustrates the construction of the table shield 100. The tableshield generally includes a covering 110 that forms one continuous loopjoined at seam 112, which is positioned on the bottom of the shield 100and aligned midline on the sled 10. From the seam 112, the bottom of thecovering 110, which is herein referred to as an under layer 111, extendsacross a foam insert or mattress M in the sled 10 and down the side ofthe table T. The under layer 111 continues to a lower extent at whichpoint it folds over itself and around the inner materials of the shield100 and becomes the outer layer 113 as it continues back up and acrossthe table, directly under the patient. The outer layer 113 then repeatsthis pattern on the other side of the table T, extending down to a lowerextent, where it folds under and once again becomes the under layer 111,which is routed back up until it reaches the seam 112.

Within the covering 110 is an x-ray blocking material 114 and severalvertical stays 104, described above, which reside in pockets 106 and canbe removed for storage. The stays 104 are shaped such that, when hangingfrom the table T, the offset geometric center of the stays 104 cause thelower edges of the side table shield 102 to curve inward.

The importance of the inward curve of the stays 104 is best seen inFIGS. 5 a and 5 b . In FIG. 5 a , the side table shields 102 hangnaturally, curving inward at the bottom due to the shape of the stays104. Shown is an x-ray tube X aimed directly up at the table T. Theradiation, indicated by arrows R, emanates from the tube X but isblocked from hitting the feet of the operator by the inwardly curvingside table shields 102.

In FIG. 5 b , the x-ray tube X is swung to the side at an oblique angle.The closer side shield 102 is passively moved to the side by the tube X.The stays 104 maintain enough rigidity so that the shield does not foldor sag into the imaging path of the tube X.

In one embodiment, attachment points for arm boards, shields or otherdevices protrude from the sled through the table shield and attach tosuch devices. In the preferred embodiment, the arm boards rotate on theattachments to the sled, such that they can be flush to the sides of thesled in the down position, parallel to the x-ray table in the neutralposition, or vertical above the sled in the up position. This allowsstowage when transferring a patient off of the bed (down position),support of the patients arms during the procedure (neutral position), orclearance of the x-ray gantry when a lateral view is desired (upposition). In addition, in the preferred embodiment, the arm boardspivot outward from the head-ward attachment, allowing the arm to abduct.This feature is important for radial arterial catheterization.

Similarly, the cross-table shield 120, which shares a similarconstruction to side table shield 102, may have vertical stays. Nocurvature is necessary for the cross-table shield 120. The shield 120 ispivotally connected to the sled sheath 19, which extends down from thesled 10. As seen in FIG. 6 , the pivotal connection between the sheath19 and the cross-table shield 120 allows the shield 120 to be movedpassively by the tube X.

Referring now to FIGS. 7-9 a pattern 150 and steps for making oneembodiment of the table shield 100 are provided. FIG. 7 provides thepattern 150 for the outer layer with dimensions given in centimeters.The pattern 150 can be broken up into four general sections, 180, 182,184 and 186.

Section 180 is the center section that is sized to extend across thewidth of an x-ray table T. As will be seen, no radiation protection isnecessary for section 180, as the purpose of section 180 is to providean anchor from which the other sections hang.

Sections 182 and 184 will form the sides of the table shields 102.Section 186 will form a table shield 102 that will hang down verticallyfrom the head of the patient. All of the shield sections 182, 184 and186 contain radioabsorbant material as well as pockets 106 for stays.The pockets 106 of sections 182 and 184 will receive shaped stays whilethe pockets 106 of section 186 may receive vertical or shaped stays.

The locations of the pockets 106 shown in the figures are suggestionsbut have yielded good results. The sections 106 a, b and c representadditional fabric sewn onto the vinyl covering 110 to form the pockets106.

Triangular sections 152 and 154 form corner wraps that proved protectionaround the side edges of the shield 100, between sections 182 and 186,and between sections 184 and 186, when the side table shields 102 arehanging down.

FIG. 8 shows the addition of the radiation blocking material 114.Notably, no radiation blocking material is placed where on thehorizontal surface of the resulting shield 100 as this would block thepatient from being imaged.

Folds are then created at the intersections between the radiationblocking material 114 and the pocket sections 106 a-c according to thefolding arrows 160, 162 and 164. Folding results in the configurationshown in FIG. 9 . Though the internal materials are illustrated in FIG.9 , one skilled in the art will realize that they are hidden by thelayer 111 that results from folding and joining the edges to form seam112.

Vertical “Flag” Shields

Turning now to FIGS. 10-12 , there is shown a patient P shrouded by awing 200 on the side and transversely by a flag 210. Transverse shieldor flag 210 includes an upper unit 212, a lower unit 214 and a lateralunit 216. The upper functional unit 212 has a degree of internalflexibility/elasticity and has a horizontal articulation 213 with thelower functional unit 214, as best shown in FIG. 12 in which arrows 220and 222 show the articulating movement of upper unit 212 relative tolower unit 214. The flag 210 also has vertical articulation 215 with thelateral functional unit 216 as indicated by arrow 224.

This articulation 213, 215 allows the upper unit 212 to freely move on ahorizontal axis as well as have some elastic stretch when the equipmentin the room such as an image intensifier pushes it to enable optimalimaging conditions. This the lower functional unit 214 is thus able toremain in place on the patient continuing to block radiation scatterfrom the patient's body while the upper unit 212 bends away and conformsto an image intensifier, for example. In addition, the flag 210 may havevertical supports throughout. The supports may contain a hinge or springapparatus to allow the flag to bend in the vertical plane so that theflag 210 is able to conform to other radiation absorbing material, suchas the wing 200, allowing the flag 210 continues to form a shell aroundthe patient to continue blocking the radiation scatter. Because the flag210 has elastic properties, when the image intensifier moves away froman interfering position, the flag 210 returns to its initial position,preventing gaps in the shielding where radiation may be emitted towardsthe HCW.

As best seen in FIG. 11 , the lower unit 214 includes bottom curves 230that contour to a patient's body habitus in order to maximize radiationprotection to the HCW. Similarly, the bottom of the lateral unit 216includes a cutout 232 to contour to a patient's forearm.

The upper, lower and lateral units 212, 214, 216 may be composed ofmultiple vertical strips of overlapping material to provide greaterflexibility with positioning the barrier around objects. Additionally,the radioabsorbent barriers on the top or bottom of the flag can becomposed of multiple overlapping material, such that an objectdisplacing one piece of material would not displace the adjacentsection. This would improve radiation protection.

The flag units 212, 214, 216 can be constructed of radioabsorbent fullyor partially transparent material or could have a radioabsorbent clearwindow (not shown) in portions to allow for optimal patientvisualization. The flag 210 also can hold a patient instruction and orentertainment window where a screen could be placed.

The flag 210 may be attached to the attachment mechanism 412 along withthe tray 420. Alternatively, the flag 210 may be anchored to themattress or patient table, to a separate free-standing mechanism, or toa wall or ceiling mount, with features that allow for rapid stowage.Like the tray 420, the flag 210 preferably has at least two, and morepreferably three or more degrees of freedom.

Vertical “Wing” Shields

The wing 200, shown in FIG. 10 , may be rigid or flexible and is aradioabsorbent wall that extends vertically along the side of thepatient, and is height-adjustable to provide a desired level ofprotection between the HCW and the patient. Wing shields 200 aredesigned for placement at various locations relative to the patient.

The wing shields 200 may be attached to the arm board or sled, andextend vertically along the side of the patient, creating a wall of adesirable height between the HCW and the patient. The wing shields canbe displaced passively by x-ray equipment. In one embodiment, the wingshields are attached to the patient arm board using a spring hinge. Thewing shield is pushed away from the patient when the x-ray system isrotated to a lateral position (such as 45 degrees right anterioroblique) and returns to its upright position when the x-ray equipment ismoved to an anterior-posterior position.

The wing may have a number of shapes depending on the room andequipment. In one embodiment, the wing shield is curved from top tobottom, contains a clear window to observe the patient, and/or hasdeflector pieces that deflect the shield when the x-ray systemapproaches the wing shield from the headward or footward edges.

Attachable Body Shields

Referring now to FIG. 13 personnel scatter radiation exposure above thetable is attenuated by attaching one or more flexible body shields 300to the sled 10. to the flexible table shield, or to the shield thatcovers the x-ray table, one or more radiation shields cover various bodyparts, but particularly the pelvis, chest and shoulder/neck areas.

In FIG. 13 , there are shown three body shields 300—a shoulder and headshield 302, a chest and abdomen shield 310, and a pelvic and leg shield320. The shoulder and head shield 302 extends from an edge of the sled10 to an area approximating the chin of the patient where it is joinedby the chest and abdomen shield 310. One or both of the shields 302 and310 join to form a neck cutout 312, which provides easy access to theneck of the patient P.

The chest and abdomen shield 310 extends to about waist level where itis joined by the pelvic and leg shield 320. The shield 320 has femoralartery cutouts 202 to align with the cutouts of the tray, if present,providing access to the femoral arteries.

Some or all of the shields 300 may have horizontally aligned stays 330that are constructed and arranged, with magnets for example, to maintaina stacked configuration, if desired, or to maintain a foldedconfiguration, if desired. Thus, the height of the body shields 300 canbe adjusted by simply folding the shields over at a desired locationbetween stays 330.

In one embodiment, rigid or flexible stays 330 keep the shield in anexpanded state while allowing the shield to conform to the body contour.Since patient and procedure needs vary, the body shields can bereversibly detachable from the table shield using a variety ofmechanisms, such as a zipper or hook and eyelet mechanism.

Radioabsorbent Tray

FIGS. 14-20 show a tray 420 of the invention. The tray 420 is agenerally horizontal tray that, in use, is positioned above the patientand provides a working surface for the physician while shielding thephysician from radiation. The tray 420 may have cutouts 422 foraccessing the femoral arteries of the patient. This obviates the need tomove the tray when using a femoral navigation approach.

The tray 420 may also include various features for holding toolssecurely, providing convenient access for the physician. For example,the tray 420 of FIG. 14 includes a well 424, which is a simple recessfor securely containing tools. FIG. 15 shows an embodiment of tray 420having several tool accommodations. In addition to providing two wells424, one of which (424 a) is used to hold needles and angioplasty wireknobs, and the other of which (424 b) is used to hold gauze in a sterilesaline solution, the tray 420 of FIG. 15 includes a light 426 forilluminating the tools, reducing eyestrain for the HCW and improvingsafety. Also shown are one or more clips 428, provided for attaching thecatheters or wires that may be attached or inserted into the patient.

The tray 420 is positioned over the patient with an attachment mechanism412, such as a swing arm or boom. The attachment mechanism 412 providesat least two, preferably three or four degrees of freedom to the trayposition, including adjustable height above the patient, horizontalrotation, horizontal translation, and vertical rotation or tilt. FIGS.16 a-d depict the adjustability provided by the attachment mechanism412.

FIG. 16 a shows the relative positions of the tray 420, the operator O,and the patient P. The tray 420 is shown with femoral cutouts 422. Alsoshown is an arrows 430, indicating the ability of the tray 420 to betranslated horizontally in the direction of the arrows 430.

FIG. 16 b shows the tray 420 rotated horizontally around a mast 414 ofthe attachment mechanism. Arrow 432 is provided to show the directionsof rotation made available by the rotational connection of the tray 420to the mast 414.

FIG. 16 c provides a side elevation of the tray 420 in a horizontalorientation. FIG. 16 d shows the tray 420 being tilted in the directionof arrow 434.

FIG. 17 shows an end elevation of the tray 420 placed over a patient Plying on a mattress M. An operator O is attending to the patient P.Three arrows, 432, 434, and 436 are shown to indicate the degrees offreedom for horizontal rotation, tilt, and vertical adjustment,respectively.

FIG. 18 is a side elevation of a tray 420 showing that the tray 420 canbe described as having two shielding components, a belly shield 421 anda side shield 423. Referring back to FIG. 17 , the benefits of the bellyshield 421 and side shield 423 are highlighted using radiation arrows R.The radiation arrows R emanate from the patient P but are blocked andabsorbed both above, and to the side of, the patient P, therebyprotecting operator O.

It is not uncommon for the need to arise to put gentle pressure on thepatient for various reasons. Pressing down on the patient during imagingnecessarily exposes the HCW to even higher doses of radiation due toclose proximity to the patient and also positioning him or herself abovethe patient to apply the pressure. FIGS. 19 a and 19 b show anembodiment of a tray 420 with a compression device 440 in the form of aballoon. The balloon 440 in FIG. 19 a is shown as deflated and thus notapplying pressure to the patient P. The balloon 440 in FIG. 19 b isshown as inflated and thus applying pressure to the patient P. Therigidity of the tray 420 and the ability of the attachment mechanism tolock the position of the tray in place, provides a stationary forceagainst which the balloon can act to apply pressure to the patient.

FIG. 20 shows a plan view of a tray 420 that has adjustable sides 442and 444. The sides 442 and 444 have a sliding connection to the rest ofthe tray 420 such that the width of the belly shield 421 may be adjustedto accommodate different patient sizes. The adjustability of the sides442 and 444 is depicted by arrows 446 and 448, respectively.

Data

An experiment was conducted to test the efficacy of the system of thepresent invention. A standard anthropomorphic X-ray phantom was acquiredfrom the US Department of Energy and placed on the table of a Toshiba®Infinix® C-arm radiographic system. The settings were as follows:

-   -   15 fr/sec fluoroscopy    -   70 keV tube voltage    -   SID 100 cm    -   103-106 mA current

Scatter radiation was measured, using a Fluke® Biomedical X2 SensorSystem, at various locations, and at various heights, throughout theroom, according to the map provided in FIG. 21 . FIG. 21 shows that 6locations were identified as corresponding to locations were HCWs wouldtypically stand as follows:

-   -   Position 1—Imaging Cardiologist    -   Position 2—Right Heart Catheterization Cardiologist    -   Position 3—Heart Biopsy Cardiologist    -   Position 4—Femoral or Radial Access Angiography Cardiologist    -   Position 5—Assistant    -   Position 6—Nurse

The graphs shown in FIGS. 22-27 each correspond to one of the positions1-6 of FIG. 21 . Measurements were taken at several heights, beginningat 1 cm from the floor and extending up to 20 cm at 1 cm intervals. Datawas gathered for both a table using standard shielding as well as usingthe shielding of the present invention (represented in the table as“Maximal”). The results show a dramatic decrease in exposure at all sixof the positions measured.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A radioabsorbent shield comprising: a flexiblesheet having at least one bottom edge and including at least one layerof radioabsorbent material; a plurality of rigid vertical stays attachedto the sheet causing the sheet to conform to the shape of the stays;wherein said stays are shaped such that, when said sheet is hung from apoint above the stays, the at least one bottom edge of the sheet ishorizontally offset from the point above the stays.
 2. Theradioabsorbent shield of claim 1 wherein said flexible sheet comprises aan outer layer and an inner layer and said at least one layer ofradioabsorbent material is sandwiched between said outer layer and saidinner layer.
 3. The radioabsorbent shield of claim 1 wherein saidflexible sheet further comprises pockets into which said stays areremovably contained.
 4. The radioabsorbent shield of claim 1 whereinsaid stays are elongate.
 5. The radioabsorbent shield of claim 1 whereinsaid stays are spaced apart from each other.
 6. The radioabsorbentshield of claim 1 wherein said stays are parallel to each other.
 7. Amethod of protecting health care workers from radiation exposure belowan x-ray table having a moveable x-ray tube located under the tablecomprising: providing a flexible radioabsorbent sheet having at leastone bottom edge; shaping the sheet vertically such that when the sheetis hung from a location on the sheet above the at least one bottom edge,the at least one bottom edge is horizontally offset from the location;hanging the radioabsorbent sheet from a point near the patient, suchthat said location on the sheet is near said point and said bottom edgeis located under the table due to the offset.
 8. The method of claim 7further comprising allowing the sheet freedom to swing outwardly whenmoved by the x-ray tube.
 9. The method of claim 7 wherein providing theflexible radioabsorbent sheet having at least one bottom edge comprisesproviding a flexible radioabsorbent sheet having two bottom edges spacedapart such that when said sheet is draped over an x-ray table, each ofthe two bottom edges are located near a floor on which the table islocated on opposite sides of the table.
 10. The method of claim 7wherein shaping the sheet vertically comprises connecting at least onerigid stay to the sheet.
 11. The method of claim 10 wherein connectingthe at least one rigid stay to the sheet comprises placing a pluralityof shaped elongate stays in vertical pockets formed in the sheet. 12.The method of claim 10 wherein hanging the radioabsorbent sheet from thepoint near the patient comprises draping the radioabsorbent sheet over asurface on which the patient lies.
 13. A radioabsorbent sheetcomprising: a first section, a second section, and a third section;wherein the first section has a width sized to span an x-ray table;wherein the second section is adjacent the first section such that whensaid sheet is draped over an x-ray table, said second section hangs offa side of the x-ray table; wherein the third section is adjacent thefirst section and opposite the first section such that when said sheetis draped over an x-ray table, said third section hangs off a side ofthe x-ray table opposite the first section; wherein said second andthird sections include: radioabsorbent material; shaped stays causingthe second and third sections to curve under the x-ray table when saidsheet is draped over the x-ray table.
 14. The radioabsorbent sheet ofclaim 13 further comprising: a fourth section adjacent the first sectionand between said second and third sections such that when said sheet isdraped over an x-ray table, the fourth sections hangs off a head of thex-ray table; wherein said fourth section includes: radioabsorbentmaterial; stays giving the fourth section vertical rigidity.
 15. Theradioabsorbent sheet of claim 13 wherein said second and third sectionstays are curved.
 16. The radioabsorbent sheet of claim 14 wherein thefourth section stays are straight.
 17. The radioabsorbent sheet of claim13 wherein said sheet comprises flexible vinyl wrapped around at leastone layer of radioabsorbent material to form a laminate.